Global Regulatory Affairs Specialist II

3 weeks ago


Wilmslow, Cheshire East, United Kingdom Waters Full time
Regulatory Affairs Specialist IIKey Responsibilities
  • Provide regulatory guidance and support to new product development teams to ensure compliance with regulatory requirements
  • Develop and maintain regulatory strategies for new and modified products
  • Prepare and execute regulatory filings, including technical files and Canadian submissions
  • Conduct international registrations and provide input on product labels and labeling
  • Support the set up and management of outside vendors
  • Provide regulatory guidance on changes to existing products and monitor global regulatory intelligence
  • Perform regulatory impact assessments for engineering changes and review promotional materials
  • Provide regulatory input to support post-market surveillance and vigilance activities
  • Support Health Hazard Assessments and Field Actions as needed
Qualifications
  • Bachelor's degree in Analytical Chemistry, Biochemistry, or Biomedical Engineering
  • Regulatory affairs experience in the In Vitro Diagnostic Medical Device environment
  • Knowledge and application of 21 CFR 820 and ISO 13485
  • Knowledge and application of the European IVD regulations, IVDR preferred
About Waters Corporation

Waters Corporation is a leading specialty measurement company, pioneering chromatography, mass spectrometry, and thermal analysis innovations

We strive to be better, learn, and improve every day in everything we do

We're united by diversity and thrive on it for the benefit of our employees, products, customers, and community

Diversity and inclusion are fundamental to our core values at Waters Corporation



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